Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands
MINJUVI is indicated in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
MINJUVI must be administered by a healthcare professional experienced in treatment of cancer patients.
A pre-medication to reduce the risk of infusion-related reactions should be administered 30 minutes to 2 hours prior to tafasitamab infusion. For patients not experiencing infusion-related reactions during the first 3 infusions, pre-medication is optional for subsequent infusions.
The pre-medication may include antipyretics (e.g. paracetamol), histamine H1 receptor blockers (e.g. diphenhydramine), histamine H2 receptor blockers (e.g. cimetidine), or glucocorticosteroids (e.g. methylprednisolone).
If an infusion-related reaction occurs (Grade 2 and higher), the infusion should be interrupted. In addition, appropriate medical treatment of symptoms should be initiated. After signs and symptoms are resolved or reduced to Grade 1, MINJUVI infusion can be resumed at a reduced infusion speed (see Table 1).
If a patient has experienced a Grade 1 to 3 infusion-related reaction, pre-medication should be administered before subsequent tafasitamab infusions.
The recommended dose of MINJUVI is 12 mg per kg body weight administered as an intravenous infusion according to the following schedule:
Each cycle has 28 days.
In addition, patients should self-administer lenalidomide capsules at the recommended starting dose of 25 mg daily on days 1 to 21 of each cycle. The starting dose and subsequent dosing may be adjusted according to the lenalidomide Summary of Product Characteristics (SmPC). MINJUVI plus lenalidomide in combination is given for up to twelve cycles.
Treatment with lenalidomide should be stopped after a maximum of twelve cycles of combination therapy. Patients should continue to receive MINJUVI infusions as single agent on day 1 and 15 of each 28-day cycle, until disease progression or unacceptable toxicity.
Table 1 provides dose modifications in case of adverse reactions. For dose modifications regarding lenalidomide, please also refer to the lenalidomide SmPC.
Table 1. Dose modifications in case of adverse reactions:
| Adverse reaction | Severity | Dosage modification |
|---|---|---|
| Infusion-related reactions | Grade 2 (moderate) | • Interrupt MINJUVI infusion immediately and manage signs and symptoms. • Once signs and symptoms resolve or reduce to Grade 1, resume MINJUVI infusion at no more than 50% of the rate at which the reaction occurred. If the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to the rate at which the reaction occurred. |
| Grade 3 (severe) | • Interrupt MINJUVI infusion immediately and manage signs and symptoms. • Once signs and symptoms resolve or reduce to Grade 1, resume MINJUVI infusion at no more than 25% of the rate at which the reaction occurred. If the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to a maximum of 50% of the rate at which the reaction occurred. • If after rechallenge the reaction returns, stop the infusion immediately. | |
| Grade 4 (life-threatening) | • Stop the infusion immediately and permanently discontinue MINJUVI. | |
| Myelosuppression | Platelet count of less than 50,000/µL | • Withhold MINJUVI and lenalidomide and monitor complete blood count weekly until platelet count is 50,000/µL or higher. • Resume MINJUVI at the same dose and lenalidomide at a reduced dose if platelets return to ≥50,000/µL. Refer to the lenalidomide SmPC for dosage modifications. |
| Neutrophil count of less than 1,000/µL for at least 7 days or Neutrophil count of less than 1,000/µL with an increase of body temperature to 38°C or higher or Neutrophil count less than 500/µL | • Withhold MINJUVI and lenalidomide and monitor complete blood count weekly until neutrophil count is 1,000/µL or higher. • Resume MINJUVI at the same dose and lenalidomide at a reduced dose if neutrophils return to ≥ 1000/µL. Refer to the lenalidomide SmPC for dosage modifications. |
The safety and efficacy of MINJUVI in children under 18 years have not been established.
No data are available.
No dose adjustment is needed for elderly patients (≥65 years).
No dose adjustment is needed for patients with mild or moderate renal impairment (see section 5.2).
There are no data in patients with severe renal impairment for dosing recommendations.
No dose adjustment is needed for patients with mild hepatic impairment (see section 5.2). There are no data in patients with moderate or severe hepatic impairment for dosing recommendations.
MINJUVI is for intravenous use after reconstitution and dilution.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
In the case of an overdose, patients should be carefully observed for signs or symptoms of adverse reactions and supportive care should be administered, as appropriate.
Unopened vial:
4 years.
Reconstituted solution (prior to dilution):
Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2°C-25°C.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. Do not freeze or shake.
Diluted solution (for infusion):
Chemical and physical in-use stability has been demonstrated for a maximum of 36 hours at 2°C-8°C followed by up to 24 hours at up to 25°C.
From a microbiological point of view, the diluted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions. Do not freeze or shake.
Store in a refrigerator (2°C-8°C).
Keep the vial in the outer carton in order to protect from light.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Clear type I glass vial with a butyl rubber stopper, aluminium seal and a plastic flip-off cap containing 200 mg tafasitamab. Pack size of one vial.
MINJUVI is provided in sterile, preservative-free single-use vials.
MINJUVI should be reconstituted and diluted prior to intravenous infusion.
Use appropriate aseptic technique for reconstitution and dilution.
Instructions for reconstitution:
Instructions for dilution:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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